Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

Stroke Clinical Trial

— Electro  

Official title:

Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698763
• Other study ID #: 3001088
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: November 23, 2009
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary objective is to explore the safety of low doses of oral levosimendan in patients with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus will be on the evaluation of proarrhythmic potential of the different dose regimens.

Description:

This is a prospective, multicentre, phase II, randomized, double-blind, placebo-controlled 2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for 13-18 days. The study population will be randomly allocated either to the levosimendan group or to the placebo group. The double-blind phase with either placebo or levosimendan is preceded by a 13-day long single-blind treatment with placebo (placebo run-in). The study consists of 9 visits (screening visit, 7 visits during the treatment period and an end-of-study visit). Each subject will be on study treatment (including placebo run-in) for 78-108 days and the duration of the study for each subject, including the screening and the end of study visit, is approximately 17 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit.

Exclusion Criteria:

• Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection

• Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute coronary event or angioplasty or any other major surgery within 1 month, any major surgery during the planned study period

• History of life-threatening ventricular arrhythmia within 3 months.

• History of Torsades de Pointes (TdP) or family history of long QT-syndrome

• Heart rate (HR) < 50 or > 100 bpm.

• Systolic blood pressure (SBP) < 100 mmHg or > 180 mmHg, or diastolic blood pressure (DBP) > 100 mmHg.

• Ventricular tachycardia.

• Episode of atrial fibrillation or atrial flutter lasting > 60 seconds.

• Second or third degree atrioventricular (AV) block.

• Potassium (K) < 3.7 mmol/l or > 5.5 mmol/l.

• Creatinine > 170 µmol/l or on dialysis.

• Blood haemoglobin <10 g/dl; clinically significant hepatic impairment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Drug:
• Levosimendan
from 0.125 mg to 2 mg in escalating doses
• Placebo
Placebo capsules are identical in appearance to active capsules

Locations

Country	Name	City	State
Finland	Helsinki University Hospital (HUCH)	Helsinki
Finland	Turku University Hospital (TYKS)	Turku
Germany	Heidelberg University Clinic	Heidelberg
Hungary	Debrecen University	Debrecen
Sweden	Sahlgrenska University Hospital, Dept of Neurology	Gothenburg
Sweden	University Hospital, Neurologmottagningen	Linköping
Sweden	Umeå University Hospital, Strokecenter NVS	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Finland,  Germany,  Hungary,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-h Holter reporting		every 2 weeks	Yes